First-Ever FDA Clearance for Cement-Augmented Pedicle Screws (ODTMag)
Medtronic plc has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first U.S. clearance for cement-augmented pedicle screws. The CD Horizon Fenestrated Screws are used with Medtronic’s HV-R Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
Metastatic bone disease has been reported to occur in 60-80% of cancer patients, most frequently among those with primary malignancies of the breast, prostate, liver, and lung.1 The spine is the most common site of bone metastasis and can be impaired by metastatic bone tumors.2 Cement-augmented screws are designed to restore spinal stability in patients whose life expectancy is insufficient to allow for fusion to occur.
To read the full feature, see it at ODTmag – First-Ever FDA Clearance for Cement-Augmented Pedicle Screws